Phase 1 dose escalation: patients enrolled in parallel to one of up to seven dose groups Phase 2 dose expansion: single group, enrolled after Phase 1 dose escalation completed
What is the purpose of this trial?
This Phase 1/2 study is intended to investigate the safety, tolerability, and radiation dosimetry of 177Lu-PSMA-R2 and further assess preliminary efficacy data in patients with metastatic castration-resistant prostate cancer (mCRPC). The Phase 1 portion of the study will determine the recommended dose of 177Lu-PSMA-R2 for radio-ligand therapy (RLT) of mCRPC, and the Phase 2 portion will expand into approximately 60 patients documenting the preliminary activity (anti-tumor response) of repeated treatments administered, continuing safety assessments and collecting QoL data.
- Trial withAdvanced Accelerator Applications International SA
- Start Date09/02/2019
- End Date12/31/2022
- Last Updated08/13/2020
- Study HIC#2000022743